Finasteride

Product NDC
31722-526
11-digit product format
317220526
Labeler code
31722
Product ID
31722-526_0ebbabf3-0681-484d-ab8d-58e670d80a0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA090060
Marketing category
ANDA
Marketing start
2013-07-01
Substance
FINASTERIDE
Active strength
1 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090060-001FINASTERIDEFINASTERIDE1MGTABLET / ORALAB2013-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090060-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-013f01610625f2…
2019-09-15 20:21 UTC2019-09A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090060-001FINASTERIDE1MGTABLET / ORALAB2013-07-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090060-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090060-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090060-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090060-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090060-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090060-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090060-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090060-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090060-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090060-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090060-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090060-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090060-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090060-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090060-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090060-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090060-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090060-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090060-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090060-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090060-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090060-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090060-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090060-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090060-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090060-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090060-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090060-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090060-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090060-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090060-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090060-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090060-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090060-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090060-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090060-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090060-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090060-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090060-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090060-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Finasteride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINASTERIDE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57GNO57U7GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200172Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00e934bb-c15b-490a-a852-839689a1231aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
d00474ae-23eb-a8eb-bf56-520e590cc6dbProduct name220170406
0f90664c-9d0e-f046-dc6a-73563cd8347eProduct name220170405

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-526-10Finasteride1000 in 1 BOTTLETABLET, FILM COATED10005
31722-526-30Finasteride30 in 1 BOTTLETABLET, FILM COATED305
31722-526-90Finasteride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-526-30EA - Each31722-526380eb51a-0b12-4fc5-943b-e992a0d382c112013-08-02
31722-526-90EA - Each31722-526a0334680-91ba-4ea6-9aff-3f9ef7125ddf12013-08-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-526FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20170901_00e934bb-c15b-490a-a852-839689a1231a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinasterideFINASTERIDEDr Reddys Laboratories Inc9acbe693-8448-b443-9f78-1f99725207982024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090060
application number: ANDA090060
FinasterideFINASTERIDENuCare Pharmaceuticals,Inc.8f2626ef-66d9-6a77-e053-2995a90af0562024-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090060
application number: ANDA090060
FinasterideFINASTERIDEAsclemed USA, Inc.b63af2cd-5c12-4977-bac4-95e1eae11e572022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090060
application number: ANDA090060
FinasterideFINASTERIDECamber Pharmaceuticals, Inc.00e934bb-c15b-490a-a852-839689a1231a2017-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090060
application number: ANDA090060
ndc (product): 31722-526

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200172finasteride 1 MG Oral TabletPSN00e934bb-c15b-490a-a852-839689a1231a5
200172finasteride 1 MG Oral TabletSCD00e934bb-c15b-490a-a852-839689a1231a5
200172FIN5C 1 MG Oral TabletSY00e934bb-c15b-490a-a852-839689a1231a5
200172finasteride 1 MG Oral TabletPSN8f2626ef-66d9-6a77-e053-2995a90af0563
200172finasteride 1 MG Oral TabletSCD8f2626ef-66d9-6a77-e053-2995a90af0563
200172FIN5C 1 MG Oral TabletSY8f2626ef-66d9-6a77-e053-2995a90af0563
200172finasteride 1 MG Oral TabletPSNb63af2cd-5c12-4977-bac4-95e1eae11e572
200172finasteride 1 MG Oral TabletSCDb63af2cd-5c12-4977-bac4-95e1eae11e572
200172FIN5C 1 MG Oral TabletSYb63af2cd-5c12-4977-bac4-95e1eae11e572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-526-10317220526101000 TABLET, FILM COATED in 1 BOTTLE (31722-526-10) 2013-07-010000-00-00NoNoCurrent
31722-526-303172205263030 TABLET, FILM COATED in 1 BOTTLE (31722-526-30) 2013-07-010000-00-00NoNoCurrent
31722-526-903172205269090 TABLET, FILM COATED in 1 BOTTLE (31722-526-90) 2013-07-010000-00-00NoNoCurrent